or labor with respect to any article refused admis- (d) Exports. A food, drug, device, or cosmetic intended for ex- REFERENCES IN TEXT The Controlled Substances Import and Export Act, re- "Section 173 of this title", as used at the end of sub- AMENDMENTS 1970 Subsec. (a). Pub. L. 91-513 substituted "Clause 1968-Subsec. (d). Pub. L. 90-399 provided that nothing 1962-Subsec. (a). Pub. L. 87-781 inserted provisions 1949-Subsec. (a). Act Oct. 18, 1949, § 1, inserted at Subsec. (b). Act Oct. 18, 1949, § 2, provided for express Subsec. (c). Act Oct. 18, 1949, § 3, charged all costs, EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91-513 effective on the first day EFFECTIVE DATE OF 1968 AMENDMENT EFFECTIVE DATE Section effective twelve months after June 25, 1938. TRANSFER OF FUNCTIONS All functions of the Federal Security Administrator See, also, note under section 321 of this title. SAVINGS PROVISION Amendment by Pub. L. 91-513 not to affect or abate SECTION REFERRED TO IN OTHER SECTIONS SUBCHAPTER IX.-MISCELLANEOUS § 391. Separability clause. If any provision of this chapter is declared uncon- EFFECTIVE DATE Section 902 (a) of act June 25, 1938, provided that this § 392. Exemption of meats and meat food products; (a) Meats and meat food products shall be exempt (b) Nothing contained in this chapter shall be of Title 42 (relating to viruses, serums, toxins, and analogous products applicable to man); the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913; the Filled Cheese Act of June 6, 1896, the Filled Milk Act of March 4, 1923; or the Import Milk Act of February 15, 1927. (June 25, 1938, ch. 675, § 902 (b), (c), 52 Stat. 1059; July 13, 1968, Pub. L. 90-399, § 107, 82 Stat. 353.) REFERENCES IN TEXT The Meat Inspection Act, approved March 4, 1907, as amended, referred to in subsec. (a), is now known as the Federal Meat Inspection Act and is classified to section 601 et seq. of this title. Act of Mar. 4, 1913, referred to in subsec. (b), is classifiled to chapter 5 of this title. The Filled Cheese Act of June 6, 1896, referred to in subsec. (b), is now covered by section 4831 et seq. of Title 26, Internal Revenue Code of 1954. The Filled Milk Act of March 4, 1923, referred to in subsec. (b), is classified to chapter 3 of this title. The Import Milk Act of February 15, 1927, referred to in subsec. (b), is classified to sections 141-149 of this title. CODIFICATION Subsecs. (a) and (b) of this section comprise respectively subsecs. (b) and (c) of act June 25, 1938. Subsecs. (a) and (d) of act June 25, 1938, which prescribed the effective date of this chapter and made appropriations available, are set out as notes under this section. AMENDMENTS 1968 Subsec. (b). Pub. L. 90-399 substituted "section 262 of Title 42 (relating to viruses, serums, toxins, and analogous products applicable to man)" for "the virus serum, and toxin Act of July 1, 1902" and inserted reference to "the virus, serum, toxin, and analogous products provisions, applicable to domestic animals, of the Act of Congress approved March 4, 1913". EFFECTIVE DATE OF 1968 AMENDMENT Amendment of subsec. (b) of this section by Pub. L. 90-399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108 (a) of Pub. L. 90-399, set out as a note under section 360b of this title. EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, provided as follows: "[Sec. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342 (c) of this title]; 403 (e) (1) [343 (e) (1) of this title]; 403 (g), (h), (1), (j), and (k) [343(g)—(k) of this title]; 501(a), (4) [351(a) (4) of this title]; 502 (b), (d), (e), (f), (g), and (h); 352 (b), (d)—(h) of this title]; 601(e); [ 361(e) of this title]; and 602(b) [362(b) of this title]. "(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940 the effective date of the provisions of sections 403 (e) (1) [343 (e) (1) of this title] 403 (g), (h), (i), (j), and (k) [343(g) (k)]; 502 (b), (d), (e), (f), (g), and (h) [352(b), (d)— (h) of this title], and 602(b) [362(b)] of this title of such Act with respect to lithographed labeling which was manufactured prior to February 1, 1939, and to containers bearing labeling which, prior to February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in such containers, where compliance with such provisions would be unduly burdensome by reason of causing the loss of valuable stocks of such labeling or containers, and where such postponement would not prevent the public interest being adequately served: Provided, That in no case shall such regulations apply to labeling which would not have complied with the requirements of the Food and Drugs Act of June 30, 1906, as amended. "Sec. 2. (a) The provisions of section 8 [section 10 of this title], paragraph fifth, under the heading 'In the case of food:', of the Food and Drugs Act of June 30, 1906, as amended, and regulations promulgated thereunder, and all other provisions of such Act to the ex tent that they may relate to the enforcement of such section 8 [section 10 of this title] and of such regulations, shall remain in force until January 1, 1940. "(b) The provisions of such Act of June 30, 1906, as amended, [sections 1-5, 7-15, and 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement imposed by section 403 [343 of this title] (k) of the Federal Food, Drug, and Cosmetic Act, shall remain in force until January 1, 1940. "(c) Notwithstanding the provisions of section 1 of this Act, such section shall not apply— "(1) to the provisions of section 502 (d) and (e) of the Federal Food, Drug, and Cosmetic Act [352 (d), (e) of this title], insofar as such provisions relate to any substance named in section 8 [former section 10 of this title], paragraph second, under the heading 'In the case of drugs:', of the Food and Drugs Act of June 30, 1906, as amended, or a derivative of any such substance; or "(2) to the provisions of section 502 (b), (d), (e), (f), (g), and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d)(h) of this title], insofar as such provisions relate to drugs to which section 505 [355 of this title] of such Act applies." EFFECTIVE DATE Section 902 (a) of act June 25, 1938, provided that: "This Act [affecting sections 1-15, 301 et seq. of this title], shall take effect twelve months after the date of its enactment [June 25, 1938]. The Federal Food and Drugs Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15), shall remain in force until such effective date, and, except as otherwise provided in this subsection, is hereby repealed effective upon such date: Provided, That the provisions of section 701 [section 371 of this title] shall become effective on the enactment of this Act, and thereafter the Secretary is authorized hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or after the effective date of this Act as the Secretary shall direct, and (2) designate prior to the effective date of this Act food having common or usual names and exempt such food from the requirements of clause (2) of section 403 (1) [section 343 (i) of this title] for a reasonable time to permit the formulation, promulgation, and effective application of definitions and standards of identity therefor as provided by section 401 [section 341 of this title]: Provided further, That sections 502(1), 505, and 601(a) [sections 352(j), 355, 361(a), respectively of this title], and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act, except that in the case of a cosmetic to which the proviso of section 601(a) [section 361 (a) of this title]. relates, such cosmetic shall not, prior to the ninetieth day after such date of enactment, be deemed adulterated by reason of the failure of its label to bear the legend prescribed in such proviso: Provided further, That the Act of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [now section 321(a) of this title]; 42 Stat. 1500, ch. 268), defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934 ed., title 21, sec. 10 [now section 321(b) of this title]; 41 Stat. 271, ch. 26), defining wrapped meats as in package form; and the amendment to the Food and Drugs Act, section 10A, approved August 27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [now section 372a of this title]), shall remain in force and effect and be applicable to the provisions of this Act." AVAILABILITY OF APPROPRIATIONS Section 902 (d) of act June 25, 1938, provided that: "In order to carry out the provisions of this Act [affecting sections 1-15, 301 et seq. of this title] which take effect prior to the repeal of the Food and Drugs Act of June 30, 1906, as amended [sections 1-15 of this title], appropriations available for the enforcement of such Act of June 30, 1906, are also authorized to be made available to carry out such provisions." SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 679 of this title. 3. Hazardous Substances 15 U.S.C. 1261-1274 Sec. (c) The term "Department" means the Depart ment of Health, Education, and Welfare. (d) The term "Secretary" means the Secretary of Health, Education, and Welfare. (e) The term "person" includes an individual, partnership, corporation, and association. (f) The term "hazardous substance" means: (1) (A) Any substance or mixture of substances which (i) is toxic, (ii) is corrosive, (iii) is an irritant, (iv) is a strong sensitizer, (v) is flammable or combustible, or (vi) generates pressure through decomposition, heat, or other means, if such substances or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children. (B) Any substances which the Secretary by regulation finds, pursuant to the provisions of section 1262(a) of this title, meet the requirements of subparagraph (1)(A) of this paragraph. (C) Any radioactive substance, if, with respect to such substance as used in a particular class of article or as packaged, the Secretary determines by regulation that the substance is sufficiently hazardous to require labeling in accordance with this chapter in order to protect the public health. (D) Any toy or other article intended for use by children which the Secretary by regulation determines, in accordance with section 1262(e) of this title, presents an electrical, mechanical, or thermal hazard. (2) The term "hazardous substance" shall not apply to economic poisons subject to the Federal Insecticide, Fungicide, and Rodenticide Act, nor to foods, drugs and cosmetics subject to the Federal Food, Drug, and Cosmetic Act, nor to substances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration system of a house, but such term shall apply to any article which is not itself an economic poison within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act but which is a hazardous substance within the meaning of paragraph 1 of this subsection by reason of bearing or containing such an economic poison. (3) The term “hazardous substance" shall not include any source material, special nuclear material, or byproduct material as defined in the Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission. (g) The term "toxic" shall apply to any substance (other than a radioactive substance) which has the capacity to produce personal injury or illness to man through ingestion, inhalation, or absorption through any body surface. (h) (1) The term "highly toxic" means any substance which falls within any of the following categories: (a) Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered; or (b) produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hunderd and three hundred grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided such concentration is likely to be encountered by man when the substance is used in any reasonably forseeable manner; or (c) produces death within fourteen days in half or more than half of a group of ten or more rabbits tested in a dosage of two hundred milligrams or less per kilogram of body weight, when administered by continuous contact with the bare skin for twentyfour hours or less. (2) If the Secretary finds that available data on human experience with any substance indicate results different from those obtained on animals in the above-named dosages or concentrations, the human data shall take precedence. (1) The term "corrosive" means any substance which in contact with living tissue will cause destruction of tissue by chemical action; but shall not refer to action on inanimate surfaces. (j) The term "irritant" means any substance not corrosive within the meaning of subparagraph (1) of this section which on immediate, prolonged, or repeated contact with normal living tissue will induce a local inflammatory reaction. (k) The term "strong sensitizer" means a substance which will cause on normal living tissue through an allergic or photodynamic process a hypersensitivity which becomes evident on reapplication of the same substance and which is designated as such by the Secretary. Before designating any substance as a strong sensitizer, the Secretary, upon consideration of the frequency of occurrence and severity of the reaction, shall find that the substance has a significant potential for causing hypersensitivity. (m) The term "radioactive substance" means a substance which emits ionizing radiation. (n) the term "label" means a display of written, printed, or graphic matter upon the immediate container of any substance or, in the case of an article which is unpackaged or is not packaged in an immediate container intended or suitable for delivery to the ultimate consumer, a display of such matter directly upon the article involved or upon a tag or other suitable material affixed thereto; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears (1) on the outside container or wrapper, if any there be, unless it is easily legible through the outside container or wrapper and (2) on all accompanying literature where there are directions for use, written or otherwise. (o) The term "immediate container" does not include package liners. (p) The term "misbranded hazardous substance" means a hazardous substance (including a toy, or other article intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is entrusted) intended, or packaged in a form suitable, for use in the household or by children, if the packaging or labeling of such substance is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of this title or if such substance, except as otherwise provided by or pursuant to section 1262 of this title, fails to bear a label (1) which states conspicuously (A) the name and place of business of the manufacturer, packer, distributor or seller; (B) the common or usual name or the chemical name (if there be no common or usual name) of the hazardous substance or of each component which contributes substantially to its hazard, unless the Secretary by regulation permits or requires the use of a recognized generic name; (C) the signal word "DANGER" on substances which are extremly flammable, corrosive, or highly toxic; (D) the signal word “WARNING" or "CAUTION" on all other hazardous substances; (E) an affirmative statement of the principal hazard or hazards, such as "Flammable", "Combustible", "Vapor Harmful", "Causes Burns", "Absorbed Through Skin", or similar wording descriptive of the hazard; (F) precautionary measures describing the action to be followed or avoided, except when modified by regulation of the Secretary pursuant to section 1262 of this title; (G) instruction, when necessary or appropriate, for first-aid treatment; (H) the word "poison" for any hazardous substance which is defined as "highly toxic" by subsection (h) of this section; (I) instructions for handling and storage of packages which require special care in handling or storage; and (J) the statement (i) "Keep out of the reach of children" or its practical equivalent, or, (ii) if the article is intended for use by children and is not a banned hazardous substance, adequate directions for the protection of children from the hazard, and (2) on which any statements required under subparagraph (1) of this paragraph are located prominently and are in the English language in conspicuous and legible type in contrast by typography, layout, or color with other printed matter on the label. The term "misbranded hazardous substance" also includes a household substance as defined in section 1471(2) (D) of this title if it is a substance described in paragraph (1) of subsection (f) of this section and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of this title. (q) (1) The term "banned hazardous substance" means (A) any toy, or other article intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is entrusted; or (B) any hazardous substance intended, or packaged in a form suitable, for use in the household, which the Secretary by regulation classifies as a "banned hazardous substance" on the basis of a finding that, notwithstanding such cautionary labeling as is or may be required under this chapter for that substance, the degree or nature of the hazard involved in the presence or use of such substance in households is such that the objective of the protection of the public health and safety can be adequately served only by keeping such substance, when so intended or packaged, out of the channels of interstate commerce: Provided, That the Secretary, by regulation, (i) shall exempt from clause (A) of this subsection articles, such as chemical sets, which by reason of their functional purpose require the inclusion of the hazardous substance involved or necessarily present an electrical, mechanical, or thermal hazard, and which bear labeling giving adequate directions and warnings for safe use and are intended for use by children who have attained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings, and (ii) shall exempt from clause (A), and provide for the labeling of, common fireworks (including toy paper caps, cone fountains, cylinder fountains, whistles without report, and sparklers) to the extent that he determines that such articles can be adequately labeled to protect the purchasers and users thereof. (2) Proceedings for the issuance, amendment, or repeal of regulations pursuant to clause (B) of paragraph (1) of this subsection shall be governed by the provisions of sections 371 (e), (f), and (g) of Title 21: Provided, That if the Secretary finds that the distribution for household use of the hazardous substance involved presents an imminent hazard to the public health, he may by order published in the Federal Register give notice of such finding, and thereupon such substance when intended or offered for household use, or when so packaged as to be suitable for such use, shall be deemed to be a "banned hazardous substance" pending the completion of issuance of such proceedings relating to the regulations. (s) An article may be determined to present a mechanical hazard if, in normal use or when subjected to reasonably foreseeable damage or abuse, its design or manufacture presents an unreasonable risk of personal injury or illness (1) from fracture, fragmentation, or disassembly of the article, (2) from propulsion of the article (or any part or accessory thereof), (3) from points or other protrusions, surfaces, edges, openings, or closures, (4) from moving parts, (5) from lack of insufficiency of controls to reduce or stop motion, (6) as a result of selfadhering characteristics of the article, (7) because the article (or any part or accessory thereof) may be aspirated or ingested, (8) because of instability, or (9) because of any other aspect of the article's design or manufacture. (Pub. L. 86-613, § 2, July 12, 1960, 74 Stat. 372; Pub. L. 89756, §§ 2(a)—(c), 3(a), Nov. 3, 1966, 80 Stat. 1303, 1304; Pub. L. 91-113, §§ 2(a), (c), (d), 3, Nov. 6, 1969, 83 Stat. 187-189; Pub. L. 91-601, § 7(a), Dec. 30, 1970, 84 Stat. 1673.) REFERENCES IN TEXT The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (f) (2), is classified to chapter 6 of Title 7, Agriculture. The Federal Food, Drug, and Cosmetic Act, refered to in par. (f) (2), is classified in chapter 9 of Title 21, Food and Drugs. The Atomic Energy Act of 1954, as amended, referred to in par. (f) (3), is classified to chapter 23 of Title 42, The Public Health and Welfare. AMENDMENTS 1970 Subsec. (p). Pub. L. 91-601 substituted in text preceding par. (1) "if the packaging or labeling of such substance is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of this title or if such substance" for "which substance" and added following and below par. (2) provision including in "misbranded hazardous substance" a household substance as defined in section 1471(2) (D) of this title if it is a substance described in par. (1) of subsec, (f) of this section and its packaging or labeling is in violation of an appli cable regulation issued pursuant to section 1472 or 1473 of this title. 1969 Subsec. (f) (1) (A). Pub. L. 91-113, § 3 (a), added "or combustible" following "is flammable". Subsec. (f) (1) (D). Pub. L. 91-113, § 2(a), added subsec. (f) (1) (D). Subsec. (1). Pub. L. 91-113, § 3(b), added the definition of the term "combustible" and expanded references to "flammability" and "flammable" to include "combustibility" and "combustible", respectively. Subsec. (p) (1) (E). Pub. L. 91-113, § 3 (c), added "Combustible" to the enumerated affirmative statements of the principal hazard or hazards required to be stated on the label of a hazardous substance. Subsec. (q) (1). Pub. L. 91–113, § 2(c), added "or necessarily present an electrical, mechanical, or thermal hazard" following "hazardous substance involved". Subsecs. (r)-(t). Pub. L. 91-113, § 2(d), added subsecs. (r)-(t). 1966 Subsec. (f). Pub. L. 89-756, § 2(a), provided that "hazardous substances" shall apply to any article which is not itself an economic poison within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act but which is a hazard substance within the meaning of par. (1) of this subsec. by reason of its bearing or containing an economic poison. Subsec. (n). Pub. L. 89-756, § 2(b), enlarged the term "label" to include, where the article is unpackaged or is packaged in an immediate container not intended or suitable for delivery to the ultimate consumer, a display of written, printed or graphic matter directly upon the article involved or upon a tag or other suitable material affixed thereto. Subsec. (p). Pub. L. 89-756, § 2(c), in the introductory material preceding par. (1) substituted "misbranded hazardous substance" for "misbranded package" and "misbranded package of a hazardous substance" and as so retermed enlarged applicability to include toys and other articles intended for use by children, which are hazardous substances, or which bear or contain hazardous substances when susceptible of access by children, and in par. (1), clause (J) added further category of "misbranded hazardous substance" where the article is intended for use by children and is not a banned hazardous substance and fails to bear a label with adequate directions for the protection of children from the hazard. Subsec. (q). Pub. L. 89-756, § 3(a), added subsec. (q). EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 9 of Pub. L. 91-601, set out as a note under section 1471 of this title. Effective Date of 1969 AMENDMENT Section 5 of Pub. L. 91-113 provided that: "The amendments made by this Act [which enacted section 1274 of this title, amended this section and section 1262 of this title, enacted provisions set out as notes under this section, and amended provisions set out as notes under this section and former section 401 of this title] shall take effect on the sixtieth day following the date of the enactment of this Act [Nov. 6, 1969].” EFFECTIVE DATE Pub. L. 86-613, § 17, formerly § 16, July 12, 1960. 74 Stat. 380, renumbered Pub. L. 91-113, § 4(a), Nov. 6, 1969. 83 Stat. 189, provided that: "This Act [adding this chapter and repealing sections 401-411 of this title] shall take effect upon the date of its enactment [July 12, 1960): but no penalty or condemnation shall be enforced for any violation of this Act which occurs "(a) prior to the expiration of the sixth calendar month after the month in which this Act is enacted [July 1960). or "(b) prior to the expiration of such additional period or periods, ending not more than eighteen months after the month of enactment of this Act [July 1960], as the Secretary may prescribe on the basis of a finding that conditions exist which necessitate the prescribing of such additional period or periods: Provided, That the Secretary may limit the application of such additional period or |